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ADHD Drugs: Sudden Death Risk Higher?

Study Suggests Link Between Some ADHD Drugs and Sudden Cardiac Death in Children

WebMD News Archive

FDA: Study Doesn’t Prove Link continued...

The biggest limitation, FDA officials said, is that information on stimulant use was collected years and in some cases a decade or more after the children died.

They expressed concern that recalling their children's stimulant use many years later might be greater for parents and physicians of children who died suddenly of unexplained causes.

Robert Temple, MD, of the FDA, said an ongoing study of cardiac outcomes among children taking stimulants for ADHD should provide additional information about risk.

Results from this study, also funded by the FDA and the Agency for Healthcare Research and Quality (AHRQ), should be published in a few months, he said.

ADHD Drugs Have Warnings

It is estimated that more than 2.5 million children and teens in the United States take stimulants to control their ADHD.

Drugs like Ritalin, Adderall, Dexedrine, and Concerta are known to increase heart rates and raise blood pressure, but the risk has not been considered significant in otherwise healthy children.

The FDA requires that these drugs include labeling warning of the risk of sudden cardiac death in patients with heart problems, but the incidence of cardiac events among children and teens taking the drugs for ADHD is not known.

In March of 2006, an FDA panel reported that between 1992 and 2005, 11 sudden cardiac deaths occurred in children taking Ritalin and Concerta, which both contain the stimulant methylphenidate, and 13 sudden cardiac deaths occurred among children taking the amphetamine-containing stimulants Adderall and Dexedrine. Three sudden cardiac deaths were also reported among children taking the ADHD drug Strattera, which is not a stimulant.

Late last year, a special panel of the American Heart Association recommended screening all children and teens taking ADHD drugs for hidden heart problems. The panel also called for electrocardiogram (ECG) screening of all patients being placed on the stimulants for the first time.

Editorial: ‘Drugs Aren’t Innocuous’

In an editorial published with the study, Benedetto Vitiello, MD, and Kenneth Towbin, MD, of the National Institute of Mental Health, write that this report “should underscore that stimulants are not innocuous and that their therapeutic use requires careful diagnostic assessment, diligent safety screening, and ongoing monitoring.”

Ritalin, Concerta, and other ADHD drugs are increasingly being used recreationally, usually in an effort to boost academic or job performance.

Vitiello tells WebMD that recreational users mistakenly think of these drugs as safe.

“These drugs are being widely misused, and people need to know that they are not benign,” he says.

A spokeswoman for McNeil Pediatrics, which makes Concerta, told WebMD that the company “welcomes any data that adds to the body of knowledge in this therapeutic area.”

Calls to Shire Pharmaceuticals, which manufactures Adderall, and Novartis Pharmaceuticals, which markets Ritalin LA, were not returned in time for publication.